MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
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Taiwan · ISO 13485 · OEM/ODM

Medical Device Component Manufacturer

PROCH Plastic Co., Ltd. integrates precision CNC machining, plastic injection molding, surface treatment coordination, inspection and assembly for medical device component projects from prototype to controlled production.

Review Program Value
Medical device bezel and button components manufactured by PROCH
PORTABLE DEVICE COMPONENTS
Precision screws and retainer medical components manufactured by PROCH
METAL FEATURES & RETAINERS
Precision medical device housing component manufactured by PROCH
PRECISION HOUSINGS
Metal + PlasticCoordinated CNC machining, molding, fit and assembly
Quality SystemsOperations supported by ISO 9001 and ISO 13485
Supplier EvidenceInspection and production records aligned to requirements
Privacy by DefaultMedical project details remain confidential unless approved
Supplier Fit

Built for engineering, sourcing and supplier-quality teams

PROCH is a suitable manufacturing partner when a project requires metal and plastic components, coordinated tolerances, documented inspection and assembly support.

PORTABLE DEVICES

Portable and handheld devices

Precision housings, structural components, buttons, bezels, endcaps, retainers and internal mechanical parts.

DIAGNOSTIC EQUIPMENT

Diagnostic and treatment equipment

Custom components and enclosures requiring dimensional control, cosmetic control and repeatable assembly fit.

SUBASSEMBLIES

Medical equipment subassemblies

Metal and plastic parts coordinated through inspection planning, fixtures, subassembly and production transfer.

Integrated Program Value

Why coordinated metal and plastic sourcing matters

A single engineering interface helps medical-device teams manage cross-part fit, cosmetic expectations and production-transfer evidence without repeating the full equipment information maintained on the Manufacturing page.

INTERFACES

Tolerance alignment across interfaces

Metal and molded mating parts are reviewed together so stack-up, fastening, clearance and assembly risks can be identified before production release.

APPEARANCE

Functional and cosmetic consistency

Dimensional requirements, surface finishes, colors and appearance criteria can be coordinated against the same approved product intent.

TRANSFER

Continuity from sample to production

Approved drawings, CTQs, inspection methods, fixtures and process conditions support a clearer handoff from prototype and pilot builds to repeat production.

Need equipment and process-level details?

The Manufacturing page is the authoritative source for machining, molding, inspection, assembly and production-control capabilities.

Manufacturing Capabilities
OEM/ODM Development Process

From confidential RFQ to controlled production

Each phase converts customer requirements into reviewed specifications, process conditions and traceable production evidence.

01NDA & RFQConfidentiality, drawings, materials, quantity and schedule
02DFM & Risk ReviewManufacturability, tolerance, CTQ, fit and process risks
03Process PlanningTooling, machining, molding, finishing and inspection methods
04Prototype & SampleDimensional, cosmetic and fit verification
05First ArticleFAI against approved drawings and specifications
06Validation SupportDefined verification, capability study and approval records
07Production TransferReleased documents, conditions, fixtures and training
08Production MonitoringInspection, traceability, change control and improvement

Preparing a medical component RFQ?

Share a non-confidential summary first, or arrange an NDA before exchanging technical files.

OEM/ODM Collaboration
Quality System & Audit Support

Evidence for supplier qualification and monitoring

Quality-system, manufacturing and traceability records can support customer technical reviews and supplier-control activities within an agreed disclosure scope.

SYSTEM

Quality System Evidence

ISO 9001 and ISO 13485 certificates, quality manual information and procedure lists within the agreed disclosure scope.

PRODUCTION

Manufacturing Evidence

FAI, inspection reports, CPK records where required, material or process records and nonconformance follow-up.

AUDIT

Audit-ready Support

Calibration, training, document control, traceability examples and onsite or remote audit support under NDA.

FDA QMSR context

The FDA Quality Management System Regulation (QMSR) became effective on February 2, 2026 and incorporates ISO 13485:2016 into the quality management system requirements of 21 CFR Part 820. Medical device manufacturers remain responsible for meeting QMSR and other applicable FDA regulatory requirements. ISO 13485 certification does not constitute FDA approval and does not replace an FDA inspection.

FDA QMSR FAQ
Certification Source

Verified in one location

ISO 9001 and ISO 13485 certificate images are maintained on the About PROCH page so customers can review the published certification source without duplicated files.

Audit Support Details
Procurement FAQ

Common supplier qualification questions

METAL + PLASTICCan PROCH manufacture both metal and plastic medical device components?

Yes. Integrated CNC machining and plastic injection molding help coordinate fit, tolerance and production requirements across both component types.

QUALITY DATAWhat verified quality capabilities does PROCH provide?

Operations are supported by ISO 9001 and ISO 13485. Confirmed capabilities include CPK ≥ 1.33 for agreed CTQs, 1 µm CMM resolution and C=0 AQL 0.4–1.0. Applicable sampling levels are selected according to product and customer quality requirements.

FDA QMSRHow does FDA QMSR relate to PROCH?

The FDA Quality Management System Regulation (QMSR) became effective on February 2, 2026 and incorporates ISO 13485:2016 into the quality management system requirements of 21 CFR Part 820. Medical device manufacturers remain responsible for meeting QMSR and other applicable FDA regulatory requirements. ISO 13485 certification does not constitute FDA approval and does not replace an FDA inspection.

RFQWhat information should be included in a request for quotation?

Provide 2D/3D data, material, quantity, finish, sample requirements, CTQs, inspection and assembly requirements, and target schedule where available.

Request for Quotation

Information for a faster technical review

Complete information helps engineering evaluate manufacturability, inspection scope, lead time and commercial assumptions earlier.

Applications & Materials
Prepare where available
  • 2D drawing and 3D CAD data with revision status
  • Material and regulatory requirements assigned by the customer
  • Prototype, pilot and estimated production quantities
  • Surface finish, texture, color and cosmetic requirements
  • CTQ dimensions, inspection and required records
  • Assembly, mating-part and functional verification requirements
  • Target sample date and production schedule